One-quarter of the government shut down early Saturday, and as the partial shutdown is expected to continue into the new year, several federal agencies will be impacted, including the FDA.
As funding for several federal agencies expired at midnight on Friday, a partial government shutdown began on Saturday and is expected to continue into the new year. While most of HHS, including the National Institutes of Health and the CDC, is already funded through 2019, other agencies will be impacted.
Beginning today, 41% of the FDA will be furloughed, with the majority of the agency considered essential or funded by user fees paid for by the drug and device industry.
On Friday, when it became clear that the shutdown was nearing, FDA Commissioner Scott Gottlieb, MD, tweeted: “I recognize the consequences of a federal shutdown to the public we serve, our employees and their families—especially during this holiday season. I know the burdens will intensify the longer there is a lapse in funding and I am doing everything possible to ease the impact.”
According to a contingency plan released by HHS, the FDA will continue specific activities within the scope of its user fee—funded programs, including those for prescription drugs, generic drugs, biosimilars, medical devices, and tobacco products. Existing critical public health challenges, including drug shortages and outbreaks related to foodborne illness and infectious diseases, will continue to be addressed.
The agency will also continue to respond to emergencies, manage high-risk recalls, pursue criminal enforcement work and civil investigations related to imminent threats to human health or life, review important entries to determine potential risks to health, and respond to other critical public health issues, as appropriate.
However, the FDA will be unable to support certain routine regulatory and compliance activities, including some medical product—related and most food-related activities.
According to STAT News, the shutdown will also effectively end a bipartisan effort to pass a piece of public health legislation that would help the government respond to public health emergencies. The legislation would reauthorize the 2006 Pandemic and All Hazards Preparedness Act, which allows the government to fund various programs that respond to health-related emergencies and helps the government work with private companies to develop medical technology for those emergencies, such as vaccines.
Various healthcare stakeholders have responded to the partial shutdown, including the American Public Health Association (AHPA).
“The administration and Congress’s inability to approve funds to keep the federal government open is unacceptable ad poses a threat to public health. This shutdown is a political failure, and AHPA urges the government to put ideology aside and reach a funding solution as soon as possible,” said Georges C. Benjamin, MD, executive director, APHA, in a statement.